Remedy Skin Repair
- Product NDC
- 53329-140
- 11-digit product format
- 533290140
- Labeler code
- 53329
- Product ID
- 53329-140_efcfafc0-8daf-3693-e053-2995a90a983f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dimethicone
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Medline Industries, LP
- Application
- M016
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2010-03-01
- Marketing end
- 0000-00-00
- Substance
- DIMETHICONE
- Active strength
- 2 g/100mL
- Pharmacologic classes
- Skin Barrier Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 53329-140 | D | Discontinued by firm | 2026-10-16 | ||
| excluded package | package | 53329-140 | 53329-140-04 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 53329-140 | 53329-140-23 | D | Discontinued by firm | 2026-10-16 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | 53329-140 | I | Inactivated by FDA | excluded / ndc_excluded.zip | e2bbac7714bc… | 27bdfed8d636… | ||
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 53329-140 | 53329-140-23 | I | Inactivated by FDA | excluded / ndc_excluded.zip | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 53329-140 | 53329-140-04 | I | Inactivated by FDA | excluded / ndc_excluded.zip | e2bbac7714bc… | 27bdfed8d636… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 7b19f89e-0a13-4d4e-a994-a46d39d008b9 | Product name | 1 | 20251120 |
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| 13c3e0af-2da2-8aec-9e17-1afd680d80c2 | Product name | 8 | 20221116 |
| c5cd4727-ac49-4409-82b1-5bd8006c3ec7 | Product name | 1 | 20171122 |
| 5e18e798-5614-cf5c-0185-38b1cb77a093 | Product name | 2 | 20160822 |
| f46c867f-cde5-4f14-a7c1-18ae3a6efd1c | Product name | 1 | 20160303 |
| ebc62596-fc97-4d03-9483-7ba095d25db7 | Product name | 1 | 20151210 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| 60c52429-fcef-eb54-2387-43bc9e4f296b | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53329-140-04 | Remedy Skin Repair | 118 mL in 1 TUBE | CREAM | 118 | 13 | |
| 53329-140-23 | Remedy Skin Repair | 946 mL in 1 BOTTLE, PUMP | CREAM | 946 | 13 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Daily Moisturizing | DIMETHICONE | Topco Associates LLC | 47e54eee-70e0-4bfa-ae77-d61a6560a9e1 | 2026-02-13 | Warnings, Adverse reactions | M016 |
| Witch Hazel | WITCH HAZEL | Topco Associates LLC | 471a9f8d-ba12-41d3-a510-20c1a13ff850 | 2026-02-13 | Warnings, Adverse reactions | M016 |
| Skin Protectant | PETROLATUM | Wakefern Food Corp. | b799229b-f7ca-494c-afde-1fd096aef66e | 2026-02-13 | Warnings, Adverse reactions | M016 |
| Diaper Rash | ZINC OXIDE | WinCo Foods, LLC | 659cc8c7-6300-41c0-a684-c5fde7f2b100 | 2026-02-12 | Warnings, Adverse reactions | M016 |
| Zinc Oxide | ZINC OXIDE | Walgreen Co. | 220f70e1-0802-4fe2-92d0-78dec557c993 | 2026-02-12 | Warnings, Adverse reactions | M016 |
| Witch Hazel | WITCH HAZEL | Walgreen Co. | 417ae199-54bb-420f-a3cf-1c096062d78c | 2026-02-12 | Warnings, Adverse reactions | M016 |
| First Aid Beauty Dry Skin Rescue Kit | COLLOIDAL OATMEAL | The Procter & Gamble Manufacturing Company | 4a93d029-d721-0bb5-e063-6294a90a17c4 | 2026-02-11 | Warnings | M016 |
| Natouch Eczema Wipes | ECZEMA WIPES | Natouch LLC | 0a9756a4-2fa9-cd19-e063-6294a90a93ad | 2026-02-10 | Warnings | M016 |
| EARTHS CARE Eczema Cream | ECZEMA | DLC Laboratories, Inc. | 17436fa0-d6c7-1052-e063-6294a90adae4 | 2026-02-09 | Warnings | M016 |
| Petrolatum | WHITE PETROLATUM | Retail Business Services, LLC | bf0c9494-0138-4346-9348-e235ca4d9e58 | 2026-02-06 | Warnings, Adverse reactions | M016 |
| Clear Anti-Itch | PRAMOXINE HCL, ZINC ACETATE | Retail Business Services, LLC | a80b8fee-2dd9-4640-a4f8-4cf940df8563 | 2026-02-06 | Warnings, Adverse reactions | M016 |
| Advanced Healing | PETROLATUM | Retail Business Services, LLC | 6e9121c8-5eb9-4d0b-86c5-b892e14bdab8 | 2026-02-06 | Warnings | M016 |
| Petrolatum | WHITE PETROLATUM | Retail Business Services, LLC | bf73c618-ed2f-4468-a51f-ff61c7b1f506 | 2026-02-06 | Warnings, Adverse reactions | M016 |
| Daily Moisturizing | DIMETHICONE | Retail Business Services, LLC | c8a876e2-0a34-4c3d-a0bc-549dd3048e8a | 2026-02-06 | Warnings, Adverse reactions | M016 |
| Petroleum | WHITE PETROLATUM | Salado Sales Inc. | f973e3a5-3b45-4842-99ce-dff676ae1f96 | 2026-02-06 | Warnings, Adverse reactions | M016 |
| Petroleum Skin Protectant | WHITE PETROLATUM | Pharmacy Value Alliance, LLC | 0ce03cd1-c48d-45cf-b11f-08bade55dcb6 | 2026-02-05 | Warnings, Adverse reactions | M016 |
| Daily Moisturizing | DIMETHICONE | Publix Super Markets, Inc. | 28ac9de4-2a63-4839-bed5-9bcc59ebeb2a | 2026-02-05 | Warnings, Adverse reactions | M016 |
| Witch Hazel | WITCH HAZEL | Publix Super Markets, Inc. | 0098c983-c518-4a14-8635-c7bdde7bff4f | 2026-02-05 | Warnings, Adverse reactions | M016 |
| TN Dickinsons Pain and Itch Relief | PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE | Dickinson Brands Inc. | 537c9c27-ee81-4920-8e3f-21edb844c9cf | 2026-02-05 | Warnings | M016 |
| Aveeno Eczema Therapy Nighttime Itch Relief Balm | COLLOIDAL OATMEAL | Kenvue Brands LLC | e3350a8f-b983-7c4d-e053-2a95a90a53f5 | 2026-02-04 | Warnings | M016 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 309917 | dimethicone 1.5 % Topical Cream | PSN | ab02322c-5862-4734-810e-7fb951c8d6a5 | 13 |
| 309917 | dimethicone 15 MG/ML Topical Cream | SCD | ab02322c-5862-4734-810e-7fb951c8d6a5 | 13 |
| 309917 | dimethicone 1.5 % Topical Cream | SY | ab02322c-5862-4734-810e-7fb951c8d6a5 | 13 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53329-140-04 | 53329014004 | 118 mL in 1 TUBE (53329-140-04) | 118 ml | 2010-03-01 | 0000-00-00 | No | No | Current |
| 53329-140-23 | 53329014023 | 946 mL in 1 BOTTLE, PUMP (53329-140-23) | 946 ml | 2017-02-08 | 0000-00-00 | No | No | Current |